A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween:

* ErlotinibHCl150mgTablets(Novopharm Limited,Canada)and * Tarceva® 150mgTablets(Hoffmann-LaRocheLimited,Canada) afterasingle-doseinhealthysubjectsunderfastingconditions.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

This is a blinded,single-dose,randomized,two-period,two-sequence,two-treatment,cross over study, designed to evaluate the comparative bioavailability of two formulations of erlotinib HCl 150mg tablets administered to healthy male and female subjects under fasting conditions.

SubjectswererandomlyassignedtooneofthetwodosingsequencesABorBA underfasting conditions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy, non-smoking, post-menopausal and/or surgically sterile female subjects
Healthy,non-smoking male subjects. Allsubjects willbe from 18 to 55 years ofage.

Exclusion criteria

Known history or presence of any clinically significant medicalcondition.
Known or suspected carcinoma.
Presence ofclinically significant gastrointestinal disease or history of malabsorption within the last year.
Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
Use of tobacco or nicotine-containing products within 6 months priorto drug administration.

Treatment and study plan

Erlotinib HCl 150 mg

Drug

Concentrations of erlotinib were measured from the samples collected over a 72 hour interval after receiving either Erotinib generic or Tarceva original. Later, after 14 days, a crossover was took place with the same measures.

dosing in each period.

Tarceva®

Drug

Tarceva® 150 mg

Primary outcomes

Bioequivalence (Biodisponibility)

Time frame: 72 hours

Compared Bioequivalence

Sponsors and collaborators

Lead sponsor

Quadras Scientific Solutions

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Oct 30, 2019
Registry last updated: Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed